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Job Details

Senior Statistician - Late R&I

Cambridge, Cambridgeshire, United Kingdom, Permanent

Posted: 33 mins ago

Description:

Senior Statistician - Late R&I

Location: Cambridge, UK

Competitive salary and benefits

*Play a critical role in making our pipeline accessible to patients.*

Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Are you a *Statistician* - experienced or in the beginning of your career? Do you have an appetite to use statistical methods to develop life-changing medicines? If you would like to apply your expertise in a global company pushing the boundaries of science - join us!
AstraZeneca is a global, *science-led, patient-focused biopharmaceutical company *that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person

Our Late RIA Biometrics team is dedicated to the development of innovative treatment of Respiratory, Inflammation and Autoimmunity (RIA) diseases. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

Welcome to Cambridge (UK), one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day.

In this role, we will give you the chance to utilise your statistical expertise in the design, analysis, and interpretation of clinical trial programs; submission and defence of regulatory filings; and the generation of evidence to support product commercialisation and reimbursement.

*Main Duties and Responsibilities*
As a Senior Statistician, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.

Focus & Challenge of Position

* Provide statistical leadership in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with minimal supervision
* Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP)
* Perform statistical analyses and create statistical text for clinical publications and other communications
* Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
* Define and lead analysis of relevant internal and external information to inform design decisions
* Provide statistical support and leadership to clinical trial teams (CTT), clinical sub-teams (CST) and product development teams (PDT) on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), and regulatory strategy
* Lead development of components of regulatory submissions (eg, briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA) and may represent AZ Statistics to Health Authorities (eg, Pre-IND and End of Phase II meetings)
* May provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice
* To represent the company's position in their contacts with external experts
* May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
* Requires juggling multiple projects with varying priorities. Requires ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate level of management
* Minimal supervision, appropriately and pro-actively consulting with key stakeholders (eg, GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality

*Knowledge, Skills & Experience Required*

* MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
* In depth knowledge of the technical and regulatory requirements related to the role
* Expert leadership capabilities to be able to lead and direct project work
* Extensive experience of Development, programme design and data analysis and interpretation
* Experience of major regulatory interactions and/or submissions
* Excellent communication skills and ability to build strong relationships
* Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally
* Ability to apply statistical expertise to complex problems, problem solving and quality focus
*Why AstraZeneca?*

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

*So, what's next? *

* Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
* Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

*Where can I find out more?*

* Our Social Media, Follow AstraZeneca on LinkedI[]()
* Follow AstraZeneca on Facebook []()
* Follow AstraZeneca on Instagram []()

Date advert opened: 24th September 2021
Date advert closed for applications: 24th October 2021

Job Details

1335372978
Fri, 24 Sep 2021 06:15:00 EST
Cambridge, Cambridgeshire, United Kingdom
Permanent